All about desiccated thyroid as a grandfathered in, yet “unapproved” drug
TIMELINE OF NDT:
Natural desiccated thyroid is a treatment that had its first medically documented use in 1891, and successfully. The details of this first and subsequent uses start of page 39 of the Stop the Thyroid Madness book. It rose in popularity and was determined quickly to be a great treatment for hypothyroidism. “Armour” was one of several brands.
In 1906 came the beginning of the FDA’s current regulations with the passage of the Pure Food and Drugs Act. This act was created to prevent the commerce of “adulterated and misbranded food and drugs”.
In 1938 came the Food, Drug and Cosmetic Act which gave the FDA authority to oversee the safety of all three of the latter. Many medications already in use, like Armour and Naturethroid, were “grandfathered in”.
In the early 1960s came the Drug Efficacy Study Implementation (DESI) by the FDA which was meant to classify drugs introduced between 1938 and 1962 as either effective, ineffective, or needing further study. That study was completed in 1969.
Then came 2006 and a new Compliance Policy Guide (CPG, updated June 20th of 2006) which targets the remaining unapproved drugs like natural desiccated thyroid and which ultimately requires the pharmaceuticals which make these drugs to “prove” their effectiveness and safety (i.e. 110 years of millions of safe and effective use of desiccated thyroid by patients is not enough for the FDA, it appears). The proof will come in an NDA (New Drug Application) and rigorous clinical trials, which are quite expensive.
An important sentence in the CPG is found in Section II A: We want to achieve these goals without adversely affecting public health, imposing undue burdens on consumers, or unnecessarily disrupting the market. In other words, all thyroid patients who know the superiority of desiccated thyroid will be keeping the FDA to task for this. (As of 2013, NDT has never gone through any known clinical trials)
In April 2009, thyroid patients in horror saw the FDA act upon the compliance by informing two generic makers to cease production, since they started long after. Time Caps Labs was warned in April (scroll down about 3/4th to the heading Unapproved New Prescription Drugs). There is no FDA-listed warning for Major Pharmaceuticals, the other generic maker, but they ceased as well.
Also by early 2009, Forest Labs reformulated the long popular and effective Armour desiccated thyroid by doing a flip-flop–raising the cellulose and lowering the sucrose. Patients were no longer able to do Armour sublingually–a huge disappointment–and they reported a return of hypothyroid symptoms and new strange ones. Many made a sad exodus from the use of Armour to other brands. We later figured out that we had to chew up the tablets to release the thyroid from the excess cellulose, but patients were not pleased. (In late 2008, one gal reported that her 3 or 4 grain Armour tablet was like taking nothing–was that the beginning of this ridiculous change?)
Also in 2009, a shortage of US-made desiccated powder occurred, first coming from the only North American manufacturer of the powder: American Labs. The stated cause was demand being greater than supply–an actual possibility since websites like STTM and patients groups were espousing how well it works to patients. The loss of the generics made this shortage from the manufacturer a critical situation for thyroid patients.
By Fall of 2009, The FDA approved that thyroid patients could send their prescriptions to Canadian Pharmacies for Erfa’s “Thyroid”. Compounding desiccated thyroid also found more business in the US.
January 2010 saw RLC Labs, the makers of Naturethroid, beginning to send out supplies of their product to pharmacies. The same started to be true with the newly formulated Armour by February (but most patients yawned about that, since the Armour now sucked for many.)
By February 2010, it became clear that Naturethroid had also been reformulated, even if differently. RLC stated that they changed the cellulose from methyl to micro as an improvement, and they removed potassium from the tablet. Information is confusing as to what really changed, since RLC became more private in their communications with patients—an attorney mandate.
In 2010, chewing the Armour tablets before swallowing, and perhaps Naturethroid, was first announced by STTM as a way to break down the hard cellulose-compacted tablets and achieve better symptom relief.
In late 2010, we suddenly see the appearance of a new generic desiccated thyroid by Acella. There are more questions than answers as to why this appeared. The FDA is more secretive than their so-called “open policy” reveals and greatly disappoints thyroid patients whose lives and health depend on desiccated thyroid. Patients like NP thyroid by Acella.
The Summer of 2012 reveals patients reporting that the batch of Armour they have received is now soft. STTM mentions this here. This is mainly with the smaller amounts. Many patients report they refuse to go back to Armour even still, not liking the pharmaceutical Abbott Labs for the way they treat patients.
2013 sees a new Westhroid-P desiccated thyroid by RLC Labs, having less fillers. STTM first mentions this in the blog here.
Read the Options for Thyroid Treatment to see all your possibilities.
Go here to read the FDA position on unapproved drugs, which seems a bit overkill when it comes to desiccated thyroid–a treatment used successfully for over 100 years.
Go here to read the FDA’s explanation of all the above dates.
Want more information about the history of natural desiccated thyroid? Chapter 2 in the revised STTM book has it!